Postoperative PainNCT06695624
Effectiveness of Bilateral Endoscopic Sphenopalatine Ganglion Block on Postoperative Pain After Septoplasty
A study testing Sphenopalatine Ganglion Block in people with Postoperative Pain, run by Umraniye Education and Research Hospital.
Trial summary
The aim of this clinical study will investigate the efficacy of sphenopalatine ganglion block in the treatment of postoperative pain.it will also be learnt whether it reduces the consumption of analgesics in postoperative pain.The main questions it aims to answer are: Will the participants' need for painkillers… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Sphenopalatine Ganglion Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Nov 2024to Jan 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants who will undergo septoplasty
- 18 to 50 years old
- ASA score 1 or 2
Who cannot join
- Under 18 or over 50 years of age
- ASA score III and above patient group
- The patient is allergic to any of the drugs used
- The patient has a contraindication to any of the drugs used
- Use of anticoagulant medication
- Failure of the patient to give consent
Show all 9Show fewer
- Being pregnant
- Those with GCS retardation such as dementia, mental retardation
- Those with diagnosed headache
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Investigation of the Effectiveness of Bilateral Endoscopic Sphenopalatine Ganglion Block in Management of Postoperative Pain After Septoplasty
The aim of this clinical study will investigate the efficacy of sphenopalatine ganglion block in the treatment of postoperative pain.it will also be learnt whether it reduces the consumption of analgesics in postoperative pain.The main questions it aims to answer are:
Will the participants' need for painkillers decrease after the operation? Can sphenopalatine ganglion block be used for postoperative pain after septoplasty? The researchers will compare 2 groups with and without sphenopalatine ganglion block to see the effectiveness of sphenopalatine ganglion block.
Read more
Participants will:
Read the information Participants have been given about the sphenopalatine ganglion block.
In case of any side effects, please contact participant's doctor.
Read the detailed description
This randomised controlled study will be conducted in Umraniye Training and Research Hospital operating room between November 2024 and January 2025 after obtaining ethics committee and patient consent. Each patient will be informed about the procedures to be performed during anaesthesia and surgery and signed informed consent will be obtained before the procedure. Patients will undergo septoplasty by the same otolaryngology team.
A total of 50 participants (25 envelopes each with Group 1 and Group 2 written inside) will be kept closed for the patients participating in the study. Upon the patient's fulfilment of the conditions suitable for the study, it will be randomly determined which group he/she will be included in. Thanks to this randomisation, conscious or unconscious manipulations in the selection of patients to the study group will be prevented.
- Conditions
- Postoperative Pain
- Being tested
- Sphenopalatine Ganglion Block
- Keywords
- sphenopalatine ganglion block, septoplasty, postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sphenopalatine Ganglion BlockProcedure or surgery
Sphenopalatine ganglion block group 4cc (80mg) 2% lidocaine + 1cc (4mg) dexamethasone in total 5cc volume will be prepared under sterile conditions before the procedure, 2.5 cc will be given to both nostrils. Sphenopalatine ganglion block will be applied by transnasal endoscopic method.
| Study group | Role | What they receive |
|---|---|---|
| group with sphenopalatine ganglion block | Active comparator | Sphenopalatine ganglion block will be performed for participants undergoing septoplasty. Receives: Procedure: Sphenopalatine Ganglion Block |
| group without sphenopalatine ganglion block | No intervention | Sphenopalatine ganglion block will not be performed for participants undergoing septoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analogue scale
Zero is equivalent to no pain and 10 indicates the worst possible pain.
Measured: 24 hours
total amount of tramadol consumption
Total tramadol consumption will be recorded in the postoperative period by fitting participants with a patient-controlled analgesia device.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study startNov 2024 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umraniye Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Senay Goksu, Umraniye Education and Research Hospital
- Investigators
- şenay göksu, MD, Principal investigator, Umraniye Education and Research Hospital Collaborators:
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06695624
- Sponsor's protocol ID
- SPGB-FULYA
- Status last verified
- Nov 2024
- First submitted
- 12 Nov 2024
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Al-Qudah M. Endoscopic sphenopalatine ganglion blockade efficacy in pain control after endoscopic sinus surgery. Int Forum Allergy Rhinol. 2016 Mar;6(3):334-8. doi: 10.1002/alr.21644. Epub 2015 Sep 15.
PubMed 26370724Ekici NY, Alagoz S. The effectiveness of endoscopic sphenopalatine ganglion block in management of postoperative pain after septal surgery. Int Forum Allergy Rhinol. 2019 Dec;9(12):1521-1525. doi: 10.1002/alr.22411. Epub 2019 Sep 5.
PubMed 31487422
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of Bilateral Endoscopic Sphenopalatine Ganglion Block in Management of Postoperative Pain After Septoplasty
- ClinicalTrials.gov ID
- NCT06695624
- Acronym / sponsor ID
- SPGB-FULYA
- Conditions
- Postoperative Pain
- Keywords
- sphenopalatine ganglion block, septoplasty, postoperative pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Umraniye Education and Research HospitalOther government
- Study start
- Nov 2024 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 19 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this clinical study will investigate the efficacy of sphenopalatine ganglion block in the treatment of postoperative pain.it will also be learnt whether it reduces the consumption of analgesics in postoperative pain.The main questions it aims to answer are:
Will the participants' need for painkillers decrease after the operation? Can sphenopalatine ganglion block be used for postoperative pain after septoplasty? The researchers will compare 2 groups with and without sphenopalatine ganglion block to see the effectiveness of sphenopalatine ganglion block.
Participants will:
Read the information Participants have been given about the sphenopalatine ganglion block.
In case of any side effects, please contact participant's doctor.
Detailed description
This randomised controlled study will be conducted in Umraniye Training and Research Hospital operating room between November 2024 and January 2025 after obtaining ethics committee and patient consent. Each patient will be informed about the procedures to be performed during anaesthesia and surgery and signed informed consent will be obtained before the procedure. Patients will undergo septoplasty by the same otolaryngology team.
A total of 50 participants (25 envelopes each with Group 1 and Group 2 written inside) will be kept closed for the patients participating in the study. Upon the patient's fulfilment of the conditions suitable for the study, it will be randomly determined which group he/she will be included in. Thanks to this randomisation, conscious or unconscious manipulations in the selection of patients to the study group will be prevented.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group with sphenopalatine ganglion block | Active comparator | Procedure: Sphenopalatine Ganglion BlockSphenopalatine ganglion block will be performed for participants undergoing septoplasty. |
| group without sphenopalatine ganglion block | No intervention | –Sphenopalatine ganglion block will not be performed for participants undergoing septoplasty |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Participants who will undergo septoplasty
- 18 to 50 years old
- ASA score 1 or 2
Key exclusion criteria (9 listed)
- Under 18 or over 50 years of age
- ASA score III and above patient group
- The patient is allergic to any of the drugs used
- The patient has a contraindication to any of the drugs used
- Use of anticoagulant medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sphenopalatine Ganglion BlockSphenopalatine ganglion block group 4cc (80mg) 2% lidocaine + 1cc (4mg) dexamethasone in total 5cc volume will be prepared under sterile conditions before the procedure, 2.5 cc will be given to both nostrils. Sphenopalatine ganglion block will be applied by transnasal endoscopic method. | Procedure or surgery | group with sphenopalatine ganglion block |
Primary outcome
visual analogue scale
Time frame: 24 hours
Zero is equivalent to no pain and 10 indicates the worst possible pain.
total amount of tramadol consumption
Time frame: 24 hours
Total tramadol consumption will be recorded in the postoperative period by fitting participants with a patient-controlled analgesia device.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Background: PubMed 26370724Al-Qudah M. Endoscopic sphenopalatine ganglion blockade efficacy in pain control after endoscopic sinus surgery. Int Forum Allergy Rhinol. 2016 Mar;6(3):334-8. doi: 10.1002/alr.21644. Epub 2015 Sep 15.
- Background: PubMed 31487422Ekici NY, Alagoz S. The effectiveness of endoscopic sphenopalatine ganglion block in management of postoperative pain after septal surgery. Int Forum Allergy Rhinol. 2019 Dec;9(12):1521-1525. doi: 10.1002/alr.22411. Epub 2019 Sep 5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
şenay göksu, MD principal investigator
Umraniye Education and Research Hospital Collaborators:
Questions about this trial
What is this clinical trial studying?
A study testing Sphenopalatine Ganglion Block in people with Postoperative Pain, run by Umraniye Education and Research Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact şenay göksu, MD (905337144852, senaytomruk@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual analogue scale (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06695624, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2024.